StrokeNCT07164612
The Effectiveness of Occupation-based Bilateral Arm Training on Motor Functions and Activity Participation Among Stroke Survivors During Inpatient Rehabilitation.
A study testing Occupation-Based Bilateral Upper Limb Training (OBBT) and Conventional therapy group in people with Stroke, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
People with stroke often experience limitations in motor functions and activity participation. Occupation-based bilateral upper limb training (OBBT) using occupations as meaningful daily activities, and as part of the therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Occupation-Based Bilateral Upper Limb Training (OBBT) and Conventional therapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteQatar
- Study dates
- Sep 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with first ischemic or hemorrhagic stroke by medical physician
- Stroke onset ≤ 6 months
- Both males and females with age 18-65 years
- Cognitive functions within normal and mild deficit (MMSE ≥ 22)
- With arm and hand upper extremity Brunnstrom stage of >3
- Free of any other neurological diseases.
Who cannot join
- participants with previous stroke
- musculoskeletal disease or sever pain affecting the upper extremities
- participant who have taken part in another rehabilitative research
- sever visual neglect or visual field deficit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qatar1 site
Hamad Medical Corporation\ Qatar Rehabilitation Institute
Doha
Huda Abdelrahim Yousef, Master degree, +97450394388, HYousef2@hamad.qa
About this study
Official title: The Effectiveness of Occupation-based Bilateral Arm Training on Motor Functions and Activity Participation Among Stroke Survivors During Inpatient Rehabilitation. A Randomized Control Trial
People with stroke often experience limitations in motor functions and activity participation. Occupation-based bilateral upper limb training (OBBT) using occupations as meaningful daily activities, and as part of the therapy. The activities in OBBT are tailored to the patient's life with the goal of boosting motivation and engagement to enhance activity performance and participation. This study is a randomized control trial that aims to explore the effect of OBBT along with the conventional therapy in comparison with the conventional therapy alone on motor functions and activity participation among stroke survivors in inpatient rehabilitation setting. This study will be conducted in Qatar Rehabilitation Institute, Hamad Medical Corporation, Doha, Qatar. Participants will be allocated randomly to either the OBBT group or the conventional therapy group. Participants in the OBBT group will receive 30 minutes OBBT program in addition to conventional therapy (90 minutes). Intervention sessions will be conducted 5 times per week over 6 weeks. The participants in the conventional therapy group will receive only the conventional therapy (90 minute). All participants will be assessed using the outcome measure immediately the day after completing the last intervention session at 4th week and 6th week.
- Conditions
- Stroke
- Being tested
- Occupation-Based Bilateral Upper Limb Training (OBBT), Conventional therapy group
- Keywords
- Stroke, Occupations, Occupation-based intervention, Occupational Therapy, Motor Activity, Motor Skills, Patient Participation
- Medical subject headings
- Stroke, Motor Activity, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupation-Based Bilateral Upper Limb Training (OBBT)Other
Intervention sessions for experimental group will be conducted 5 times per week over 6 weeks. OBBT will be used to engage both upper limbs simultaneously in simulate real-life functional tasks which tailored to individual needs, focusing on improving the patient's ability to perform daily activities such as dressing, washing, and cooking. The training will emphasize occupation-specific repetitive practice for at least two selected occupations and encouraged active participation of both hands during functional tasks to improve use of both upper limb motor functions and activity participation. Additionally, it will seek to support stroke survivors in their pursuit of an independent, productive, and functional recover.
Conventional therapy groupOther
Conventional therapy includes passive and active range of motion exercises, strengthening exercises, basic functional activities and mobility training, and activities designed to improve muscle tone and mobility in the affected upper limb among stroke survivors. The conventional therapy sessions will be delivered 5 times per week for 90 minutes over 6 weeks. Therapy sessions will be individualized to the participant's needs and will be provided by senior occupational therapists.
| Study group | Role | What they receive |
|---|---|---|
| OBBT group | Experimental | Participants in the experimental group will receive face- to- face individual 30 minutes OBBT program in addition to conventional therapy. These 30 -minute OBBT session will be added to the standard conventional therapy sessions (90 minutes). Receives: Other: Occupation-Based Bilateral Upper Limb Training (OBBT) |
| Conventional Therapy (control group) | Other | Participants in the control group will receive conventional therapy consisting of standard rehabilitation approaches for upper limb impairments. Receives: Other: Conventional therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment (FMA)
More than 80% of studies use the Fugl-Meyer Assessment, making it the most popular outcome measure for evaluating upper limb motor function recovery after stroke. The assessment consists18 items for the shoulder, elbow, 5 items for the wrist, 7 items for the hand and fingers, and 3 items for upper extremity coordination. The total Fugl-Meyer Assessment (FMA) motor function score for the upper extremity is 66, with higher scores indicating greater motor performance.
Measured: At baseline, immediately post 4th weeks, and 6th week of the intervention.
Secondary outcomes (4)
Action Research Arm Test (ARAT)
To examine the motor function for the paretic side. Action Research Arm Test consists 19 items distributed into 4 subscales of grasp, grip, pinch and gross movement. The total score on the Action Research Arm Test (ARAT) is 57, with higher scores indicating better motor performance.
Measured: It will be conducted at baseline, immediately post 4th weeks, and 6th week of the intervention.
Functional independence measure (FIM)
Functional Independent Measure (FIM) will be used to evaluate functional independence in activities such as self-care, sphincter control, transfer, locomotion, communication, and social cognition. It includes 18 items total, with a maximum score of 7 and a minimum score of 1, for a total score of 126. Higher score means more independent.
Measured: At baseline, immediately post 4th weeks, and 6th week of the intervention.
Stroke Impact Scale (SIS)
Stroke Impact Scale (SIS) will be used to detect the progress in stroke recovery. It includes 64 items into 8 parts including, strength, Activities of Daily Living, Instrumental Activities of Daily Living, mobility, hand function, memory and communication, emotion and participant. The Stroke Impact Scale (SIS) is a continuous measure ranging from 0 to 100, where 0 indicates no recovery and 100 indicates full recovery. Higher scores reflect greater perceived recovery.
Measured: At baseline, immediately post 4th weeks, and 6th week of the intervention.
Canadian Occupational Performance Measure (COPM)
Canadian Occupational Performance Measure (COPM) will be used to measure occupational performance ability. It includes a four stage, semi-constructive meeting session, participants will be asked to consider their goals, needs, and expectations for their daily lives. Performance and satisfaction with the chosen activity will then be measured on a 10 point scale with higher score means a greater performance and satisfaction.
In this study participant's choice of occupation-based activities and improvement in their performance and satisfaction, before and after the intervention, will be assessed using COPM.
Measured: At baseline, immediately post 4th weeks, and 6th week of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164612
- Sponsor's protocol ID
- MRC-01-25-298
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dembele J, Triccas LT, Amanzonwe LER, Kossi O, Spooren A. Bilateral versus unilateral upper limb training in (sub)acute stroke: A systematic and meta-analysis. S Afr J Physiother. 2024 Jan 23;80(1):1985. doi: 10.4102/sajp.v80i1.1985. eCollection 2024.
PubMed 38322652Kim SH, Park JH. The Effect of Occupation-Based Bilateral Upper Extremity Training in a Medical Setting for Stroke Patients: A Single-Blinded, Pilot Randomized Controlled Trial. J Stroke Cerebrovasc Dis. 2019 Dec;28(12):104335. doi: 10.1016/j.jstrokecerebrovasdis.2019.104335. Epub 2019 Sep 30.
PubMed 31582271Meng G, Meng X, Tan Y, Yu J, Jin A, Zhao Y, Liu X. Short-term Efficacy of Hand-Arm Bimanual Intensive Training on Upper Arm Function in Acute Stroke Patients: A Randomized Controlled Trial. Front Neurol. 2018 Jan 19;8:726. doi: 10.3389/fneur.2017.00726. eCollection 2017.
PubMed 29403422Renner CIE, Brendel C, Hummelsheim H. Bilateral Arm Training vs Unilateral Arm Training for Severely Affected Patients With Stroke: Exploratory Single-Blinded Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 Jul;101(7):1120-1130. doi: 10.1016/j.apmr.2020.02.007. Epub 2020 Mar 4.
PubMed 32145277Stoykov ME, Lewis GN, Corcos DM. Comparison of bilateral and unilateral training for upper extremity hemiparesis in stroke. Neurorehabil Neural Repair. 2009 Nov;23(9):945-53. doi: 10.1177/1545968309338190. Epub 2009 Jun 16.
PubMed 19531608Summers JJ, Kagerer FA, Garry MI, Hiraga CY, Loftus A, Cauraugh JH. Bilateral and unilateral movement training on upper limb function in chronic stroke patients: A TMS study. J Neurol Sci. 2007 Jan 15;252(1):76-82. doi: 10.1016/j.jns.2006.10.011. Epub 2006 Nov 28.
PubMed 17134723
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Occupation-based Bilateral Arm Training on Motor Functions and Activity Participation Among Stroke Survivors During Inpatient Rehabilitation. A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07164612
- Acronym / sponsor ID
- MRC-01-25-298
- Conditions
- Stroke
- Keywords
- Stroke, Occupations, Occupation-based intervention, Occupational Therapy, Motor Activity, Motor Skills, Patient Participation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People with stroke often experience limitations in motor functions and activity participation. Occupation-based bilateral upper limb training (OBBT) using occupations as meaningful daily activities, and as part of the therapy. The activities in OBBT are tailored to the patient's life with the goal of boosting motivation and engagement to enhance activity performance and participation. This study is a randomized control trial that aims to explore the effect of OBBT along with the conventional therapy in comparison with the conventional therapy alone on motor functions and activity participation among stroke survivors in inpatient rehabilitation setting. This study will be conducted in Qatar Rehabilitation Institute, Hamad Medical Corporation, Doha, Qatar. Participants will be allocated randomly to either the OBBT group or the conventional therapy group. Participants in the OBBT group will receive 30 minutes OBBT program in addition to conventional therapy (90 minutes). Intervention sessions will be conducted 5 times per week over 6 weeks. The participants in the conventional therapy group will receive only the conventional therapy (90 minute). All participants will be assessed using the outcome measure immediately the day after completing the last intervention session at 4th week and 6th week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OBBT group | Experimental | Other: Occupation-Based Bilateral Upper Limb Training (OBBT)Participants in the experimental group will receive face- to- face individual 30 minutes OBBT program in addition to conventional therapy. These 30 -minute OBBT session will be added to the standard conventional therapy sessions (90 minutes). |
| Conventional Therapy (control group) | Other | Other: Conventional therapy groupParticipants in the control group will receive conventional therapy consisting of standard rehabilitation approaches for upper limb impairments. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with first ischemic or hemorrhagic stroke by medical physician
- Stroke onset ≤ 6 months
- Both males and females with age 18-65 years
- Cognitive functions within normal and mild deficit (MMSE ≥ 22)
- With arm and hand upper extremity Brunnstrom stage of >3
Key exclusion criteria (4 listed)
- participants with previous stroke
- musculoskeletal disease or sever pain affecting the upper extremities
- participant who have taken part in another rehabilitative research
- sever visual neglect or visual field deficit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupation-Based Bilateral Upper Limb Training (OBBT)Intervention sessions for experimental group will be conducted 5 times per week over 6 weeks. OBBT will be used to engage both upper limbs simultaneously in simulate real-life functional tasks which tailored to individual needs, focusing on improving the patient's ability to perform daily activities such as dressing, washing, and cooking. The training will emphasize occupation-specific repetitive practice for at least two selected occupations and encouraged active participation of both hands during functional tasks to improve use of both upper limb motor functions and activity participation. Additionally, it will seek to support stroke survivors in their pursuit of an independent, productive, and functional recover. | Other | OBBT group |
| Conventional therapy groupConventional therapy includes passive and active range of motion exercises, strengthening exercises, basic functional activities and mobility training, and activities designed to improve muscle tone and mobility in the affected upper limb among stroke survivors. The conventional therapy sessions will be delivered 5 times per week for 90 minutes over 6 weeks. Therapy sessions will be individualized to the participant's needs and will be provided by senior occupational therapists. | Other | Conventional Therapy (control group) |
Primary outcome
Fugl-Meyer Assessment (FMA)
Time frame: At baseline, immediately post 4th weeks, and 6th week of the intervention.
More than 80% of studies use the Fugl-Meyer Assessment, making it the most popular outcome measure for evaluating upper limb motor function recovery after stroke. The assessment consists18 items for the shoulder, elbow, 5 items for the wrist, 7 items for the hand and fingers, and 3 items for upper extremity coordination. The total Fugl-Meyer Assessment (FMA) motor function score for the upper extremity is 66, with higher scores indicating greater motor performance.
4 secondary outcomes
Action Research Arm Test (ARAT)
Time frame: It will be conducted at baseline, immediately post 4th weeks, and 6th week of the intervention.
Functional independence measure (FIM)
Time frame: At baseline, immediately post 4th weeks, and 6th week of the intervention.
Stroke Impact Scale (SIS)
Time frame: At baseline, immediately post 4th weeks, and 6th week of the intervention.
Canadian Occupational Performance Measure (COPM)
Time frame: At baseline, immediately post 4th weeks, and 6th week of the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Background: PubMed 38322652Dembele J, Triccas LT, Amanzonwe LER, Kossi O, Spooren A. Bilateral versus unilateral upper limb training in (sub)acute stroke: A systematic and meta-analysis. S Afr J Physiother. 2024 Jan 23;80(1):1985. doi: 10.4102/sajp.v80i1.1985. eCollection 2024.
- Background: PubMed 31582271Kim SH, Park JH. The Effect of Occupation-Based Bilateral Upper Extremity Training in a Medical Setting for Stroke Patients: A Single-Blinded, Pilot Randomized Controlled Trial. J Stroke Cerebrovasc Dis. 2019 Dec;28(12):104335. doi: 10.1016/j.jstrokecerebrovasdis.2019.104335. Epub 2019 Sep 30.
- Background: PubMed 29403422Meng G, Meng X, Tan Y, Yu J, Jin A, Zhao Y, Liu X. Short-term Efficacy of Hand-Arm Bimanual Intensive Training on Upper Arm Function in Acute Stroke Patients: A Randomized Controlled Trial. Front Neurol. 2018 Jan 19;8:726. doi: 10.3389/fneur.2017.00726. eCollection 2017.
- Background: PubMed 32145277Renner CIE, Brendel C, Hummelsheim H. Bilateral Arm Training vs Unilateral Arm Training for Severely Affected Patients With Stroke: Exploratory Single-Blinded Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 Jul;101(7):1120-1130. doi: 10.1016/j.apmr.2020.02.007. Epub 2020 Mar 4.
- Background: PubMed 19531608Stoykov ME, Lewis GN, Corcos DM. Comparison of bilateral and unilateral training for upper extremity hemiparesis in stroke. Neurorehabil Neural Repair. 2009 Nov;23(9):945-53. doi: 10.1177/1545968309338190. Epub 2009 Jun 16.
- Background: PubMed 17134723Summers JJ, Kagerer FA, Garry MI, Hiraga CY, Loftus A, Cauraugh JH. Bilateral and unilateral movement training on upper limb function in chronic stroke patients: A TMS study. J Neurol Sci. 2007 Jan 15;252(1):76-82. doi: 10.1016/j.jns.2006.10.011. Epub 2006 Nov 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupation-Based Bilateral Upper Limb Training (OBBT) and Conventional therapy group in people with Stroke, run by Hamad Medical Corporation at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huda Abdelrahim Yousef, MSc. (+97450394388, HYousef2@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (FMA) (time frame: At baseline, immediately post 4th weeks, and 6th week of the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07164612, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.